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A Guide to ISO 10993-18’s Analytical Evaluation Threshold

A Guide to ISO 10993-18’s Analytical Evaluation Threshold

Jun 19, 2020 | Medical Device Testing, Regulatory, Technical Expertise

New identification standards are putting pressure on manufacturers’ submissions. Make sure your sensitivity is up to regulations.

 

Medical Device Regulation (MDR) and recent International Organization for Standardization (ISO) revisions emphasize the importance of chemical characterization studies and toxicological risk assessments. To ensure successful implementation of both, establishing the analytical evaluation threshold (AET) is key.

Let’s take a closer look at common questions related to the AET, as well as issues you’ll want to keep in mind as you plan for an MDR submission.

What is the purpose of the AET?

The purpose of the AET is to make sure toxicologists and chemists are on the same page. It establishes a concentration threshold for chemical identification, setting stricter requirements for the analytical method sensitivities that labs use and the thresholds they set during chemistry studies. Since chemical characterization requires understanding the level of sensitivity (expressed in units such as µg/mL or mg/L) and toxicology focuses on the threshold at which a chemical could present a risk to patients (as expressed in µg/kg/day), collaboration is critical in designing successful studies.

Why is the AET important?

The AET informs both chemical characterization and toxicological risk assessment decisions, setting the baseline at which chemicals should be identified and reported. If manufacturers don’t understand the importance of the AET, it could result in regulatory setbacks and added costs.

Being aware of the AET is also important because during the submission process, regulators will review your analytical report to determine if the AET was set and whether you met it. If your product hasn’t met it, you’ll need to provide substantial justification for why not; if regulators don’t find your justification acceptable, they might ask you for more information or insist that you put your devices through additional testing.

How is the AET determined?

Ideally, the AET is set through collaboration with a toxicologist, a chemist, and the manufacturer. It’s based on the dose-based threshold (DBT), the lab extraction volume, and the number of the devices used in the extraction. The number of devices used clinically will also be a factor, as will the expected duration of patient use. For example, devices that typically have contact with patients for 30 days or less have a higher threshold (say, 120 µg/day) because the risk associated with exposure for this amount of time is lower. If the device you’re testing will be used for a longer amount of time, the threshold itself will be lower (1.5 µg/day, for example).

Most extractable studies will utilize one of these thresholds to set the AET. If you’re evaluating specific compounds in a targeted study, your toxicologist should select the threshold specific to that chemical, based on contact type and duration of device usage.

What is the manufacturer’s role in the AET?

Ensuring that the AET is correctly applied to the testing process is a collaborative effort, but ultimately, it falls upon the manufacturer to make sure the standard is met. You’ll be the one to submit the report to regulators. You’ll also have to do your due diligence ahead of testing and make sure your lab is aware of the AET requirement. And you can’t wait until it’s time to prepare your submission to check for AET compliance, as that will risk potentially needing to re-test in order to reach the correct sensitivity. The best course of action is to ask your lab before testing begins if they are equipped with the necessary tools to identify all compounds that are at or above the applicable AET.

Also, you should be aware that your role doesn’t end with confirming that this is the case. It’s also your responsibility to communicate with the toxicologist and the chemist involved – both will need as much information as possible to make sure the appropriate AET is applied.

Should you test in-house or through an outside lab?

If you decide to test in-house, you’ll want to make sure your team is thoroughly trained on the AET requirement and that you have the infrastructure needed to perform complete identification. Additionally, using a third-party testing partner can also avoid the possibility of regulators seeing the results biased.

Meanwhile, if you work with an outside lab, you’ll be able to utilize their expertise, specialized methodologies, equipment, and personnel. Before you partner with them, be sure to ask the right questions and determine their competencies, especially when it comes to their familiarity with recent updates to ISO 10993-18. For example, if they already use the AET in their testing protocols, you can be confident that you will avoid setbacks and obstacles during the testing process.

As you strategize for meeting MDR compliance, don’t forget to keep in mind the individual standards you’ll need to test against. For some, the adjustment can mean revising timelines and expected costs. We recommend creating a game plan now, including the AET you’ll use and whether you will test in-house or with an external partner. Doing so will help make sure you’re ready for the upcoming changes in regulation.

 

WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.
For more information, please visit: http://www.wuxiapptec.com

 

 

 

6 MDR Facts to Not Lose Sight of

6 MDR Facts to Not Lose Sight of

Jun 11, 2020 | MDR, Medical Device, Medical Device Testing, Regulatory

Despite the progress your company has made in preparing for the MDR, don’t overlook how these easy-to-miss factors affect your work.

 

With the Medical Device Regulation (MDR) delayed until May 26, 2021, we all have some breathing room, but it’s still important to keep full steam ahead. No matter where you are along the preparation and implementation process, the following are important reminders to ensure your submissions are compliant and completed on time.

1) No devices will be eligible for grandfathering under the MDR.

Your legacy products may have been in the market for years without issue. However, submission data must be clinically proven with technical documentation demonstrating device safety and conformity with the MDR, rather than justifying past data that isn’t sufficient from a technical standpoint. While the Medical Device Directive (MDD) approved submissions with supplemental biocompatibility data, all medical device submissions must show robust data to satisfy the MDR’s newest standards.

2) MDR requirements will hold your documentation to the latest standards, but your testing procedure may not be held to those standards.

While you will need to submit complete data packages for all of your devices, the upside is you may not be required to undergo completely new testing to satisfy the standards enforced under the MDR. Regulators will accept testing documentation that doesn’t follow the latest standard, as long as the resulting data still complies.

3) Identifying carcinogens, mutagens, reproductive toxicants and endocrine disruptions applies at 0.1% or above to all invasive devices, regardless of contact duration or class.

Under the MDD, if a device were to be in contact with a patient for less than 24 hours, these identifications wouldn’t face the same level of scrutiny. However, under the MDR, there will be less distinction regarding risk, based on the duration of exposure. Many manufacturers will be directed back to chemistry testing to find answers to questions they haven’t answered before.

4) Expect a shortage of biocompatibility specialists in the foreseeable future.

During the transition to the MDR, staffing for both normal operations and MDR operations put tension on the labor market for biocompatibility specialists. With limited capacity both internally and with contracted partners, it’s essential to plan accordingly and identify areas where you may require additional support early on.

5) Capacity in testing laboratories is limited, which could backlog your submission timeline.

The longer you wait to communicate your submission strategy and timeline with testing labs, the longer it will take to secure a spot in line. Some contract research organizations that perform such testing have taken steps to expand their capacity for MDR preparation, but there are no guarantees.

6) The number of notified bodies for the MDR is greatly limited.

Currently, there are only 13 approved notified bodies. This is a drastic reduction from the capacity under the MDD, when there were more than 100 notified bodies. It’s also important to note that once a notified body is approved under the MDR, it will no longer accept submissions under the MDD.

MDR readiness is no small feat. Clearing up common misconceptions and identifying potential hurdles enables progress, there is always more to learn. If you’d like to share additional tips or info that manufacturers should know as they prepare for MDR, please reach out on our LinkedIn page.

WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.”

 

For more information, please visit: http://www.wuxiapptec.com

 

 

Class Ir Extension Granted, but Don’t Slow Down

Class Ir Extension Granted, but Don’t Slow Down

Jun 9, 2020 | MDR, Medical Device, Medical Device Testing, Regulatory

Despite the Class Ir MDR deadline extension, manufacturers must keep pace with compliance efforts to prepare for more potential, unpredictable turns.  

 

As preparations for the EU Medical Device Regulation (MDR) continue, many manufacturers are relieved to have been granted a four-year deadline extension for Class I reusable devices (Class Ir), giving them until May 26, 2024 to comply. While the extra breathing room is beneficial for Notified Bodies (NBs), manufacturers and testing labs alike, it is important to remain proactive and make the most of this additional time.

 

Many Class Ir manufacturers were facing close calls under the original 2020 MDR deadline – which has also been delayed one year until 2021 – and tight timelines could reemerge, if the reality of capacity constraints and timing is not top of mind. As you approach Class Ir device MDR preparation, be sure to consider potential challenges that won’t necessarily resolve with extra time.

 

Beware of bottlenecks

While bottlenecks can occur at any point in the validation process, NBs arguably needed the relief of this extension more than anyone. Many have faced long delays in obtaining approval to operate under the MDR, and several are still waiting. Further, several NBs previously running under the MDD decided not to pursue MDR designation, which exacerbates capacity constraints for remaining NBs. As pressure builds, delaying lower-risk Class Ir devices provided one opportunity to relieve regulators.

 

As NBs continue down unpredictable timelines, you must keep a foot on the gas. It is unclear where exactly Class Ir devices fit into regulator priorities with this extension, so you should be prepared at a moment’s notice to provide your data to a NB. Treat your preparation timeline as if nothing has changed. You can also use this given time to reevaluate devices you may have previously shelved, as this could be the perfect opportunity to bring those under the MDR.

 

Sweeping changes

Preparing Class Ir devices for submission under the MDR has become a much more extensive process for most manufacturers. Historically, Class Ir devices were self-designated, meaning manufacturers decided what validation entailed. Moving forward, this will no longer be true. To obtain a CE mark under the MDR, you must provide a detailed technical file that attests to your device’s safety, efficacy of cleaning, disinfection and the required sterilization methods as outlined in the instructions for use (IFU). A NB will review the technical file, including validations, to confirm compliance.

 

The testing process

The first step of testing is to conduct a gap analysis to help evaluate where deficiencies exist in your product portfolio data. To start, review the technical file for each of your Class Ir devices to help identify missing information or outdated test strategies. Prioritize your legacy devices, as these will be the most time-consuming. Keep in mind that NBs will not take your product’s past performance or reviews into consideration—you’ll need the data to back it up.

 

If you identify gaps in the data, you will need to run a validation test to rectify this and gather supplemental information. Depending on time constraints and resources required, it might be more efficient to partner with a contract research organization (CRO) or external testing lab. An outside partner will be able to perform the appropriate tests and develop experimental design and validation methods to help ensure compliance with the MDR.

 

Validation studies

If you determine you need to proceed with validation testing, identify the types of studies necessary for your product or product family. Validation protocols will be developed and customized to your product, its IFU and its worst-case conditions. Here are a few examples of the studies that may be required:

 

  • Cleaning efficacy studies confirm your cleaning process is reliable, repeatable and meets clean endpoints.

 

  • Sterilization efficacy studies are similar to cleaning efficacy studies and are used to verify that the sterilization methods successfully achieve a targeted sterility assurance level (SAL).

 

  • Dry time validations must be provided to healthcare facilities to accompany the steam sterilization cycle.

 

  • Disinfection validations, separate from a cleaning validation, supplement documentation that demonstrates selected disinfectants can reduce microorganisms to acceptable levels on the medical device.

 

  • Support for functionality studies includes exposing devices to multiple cleaning, disinfection and/or sterilization processes.

 

As you plan for the above validation studies, be aware of the expense and time needed to complete each one. Consulting with a CRO or external lab will be helpful, as they can ensure testing stays on schedule and adheres to the ever-changing technical and regulatory landscape.

 

It is crucial to remain full steam ahead with your MDR preparations. Since the number of NBs is shrinking, be prepared that those you have used in the past may have limited capacity or be unavailable.

 

Being proactive and keeping an urgent pace in your preparation of Class Ir submissions will help make the most of the deadline extension. We recommend that you get in touch with your NB – and your CRO or external lab partner, if you are working with one – as soon as possible. If you are unsure about engaging a testing partner, check out “MDR readiness: When to outsource.”

 

WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.”

 

For more information, please visit: http://www.wuxiapptec.com

 

Is Your Testing Program Ready for the EU MDRs?

Is Your Testing Program Ready for the EU MDRs?

Feb 18, 2020 | MDR, Medical Device, Medical Device Testing, Regulatory, Technical Expertise

The new EU regulations will require much more documentation and perhaps some new evaluations from medical device manufacturers. An expert explains how to perform a gap analysis and begin preparing now for May 2020.

The European Union’s new Medical Device Regulations (EU MDR) will require that all medical devices – even legacy products – have updated clinical data and technical documentation to support device safety and conformity with the new regulatory standards, Sandi Schaible tells MD+DI. Schaible is the senior director of analytical chemistry at WuXi AppTec, where she specializes in extractables and leachables studies. She is a U.S. delegate and international delegate for ISO 10993 part 18 in chemical characterization. She is also a U.S. delegate for ISO 10993 part 13 and the particulates committee.

MD+DI asked Schaible a few questions about what medical device manufacturers can expect with the new requirements and what steps they can take now to prepare.

What do medical device manufacturers need to know about how the EU MDR will change requirements for medical device testing and data documentation, both pre and post CE marking?

Schaible: MDR requires that you provide robust data to demonstrate the performance and safety of your device. Regulators will be looking to see that the device has been challenged under harsh conditions and that all chemical, toxicological, and biocompatibility information has been accounted for. The new standards will place more emphasis on the importance of chemistry. Be sure that no unknown substances surface in your chemistry reports, and in the case that unknowns do appear, you should be prepared to repeat your testing or provide supplemental information.

If your device is a Class I reusable device (Class Ir), a notified body must review the device’s technical file to confirm compliance before you can obtain a new CE mark. The technical file should prove the safety and efficacy of the cleaning, disinfection, and sterilization processes outlined in the device’s Instructions for Use (IFUs). While OEMs have been permitted to self-designate their devices as Class Ir in the past, this will not be the case under MDR. Additionally, Class Ir devices cannot be grandfathered in or receive extensions, so prioritizing these devices is prudent.

What are the risks to a medical device manufacturer’s product portfolio?

Schaible: The risks of unpreparedness are vast. Failure to act with urgency could lead to time-consuming regulatory delays, additional costs, wasted resources, or, worst of all, having a device pulled from the EU market. Since both new and legacy products will require updated technical data, millions of devices need to be reviewed in a short amount of time. If your submission is not bulletproof before it reaches regulators the first time around, you may have to perform additional testing before you can get back in line, jeopardizing your device and revenue streams.

How is testing changing, how will consensus standards help, and what should medical device manufacturers ask of standards bodies, notified bodies, and supplier partners?

Schaible: Performing complete biological evaluations will be of greater importance under MDR. For this reason, all medical devices must address three sequential stages of preclinical safety testing – chemical characterization, toxicological risk assessment, and biocompatibility evaluations. Another important factor to take into consideration is the reclassification of devices under MDR. For example, devices that were previously considered accessories may now fall into a whole new device category, such as Class Ir. Knowing what class your device falls into is important when it comes to planning and prioritization during the gap analysis and pre-clinical testing stages.

As testing changes, consensus standards create more consistent and updated benchmarks for the global marketplace of medical devices. New changes, like those to ISO 11607 Parts 1 and 2, aim to harmonize terminology and facilitate a mutual understanding of expectations. This is especially important in emerging marketplaces, as it brings medical devices onto a level playing field.

Working with various stakeholders like standard bodies, notified bodies, and other partners can get complicated, but asking the right questions will help kick off conversations in the right direction. Here are some key questions to ask:

  • CRO or laboratory testing partner: Does your laboratory conduct chemical characterization, toxicological risk assessments, and biocompatibility testing in-house? Enlisting a partner that has all three capabilities in-house increases efficiency, allows you to address required endpoints, and helps eliminate information gaps. If you have to piecemeal testing, it can cause longer timelines, increased cost, miscommunication between parties, loss of information altogether, and unknown impurities getting missed in your chemical reports.
  • CRO or laboratory testing partner: How do you perform E/L studies for complete identification? Changes to the ISO 10993 standard will require the identification of compounds about the analytical evaluation threshold (AET). If the laboratory you’re working with reports unknowns, you can run into problems with your risk assessment and ultimately your submission. If regulators reject your submission or issue requests for additional information, you may be required to re-test the device.
  • CRO or laboratory testing partner: Do your analytical methods provide enough sensitivity for the toxicological risk assessment? Analytical test methods that are not sensitive enough to detect chemicals above the analytical evaluation threshold may lead to challenges for the toxicologist writing the risk assessment and ultimately your submission. Make sure the testing laboratory and toxicologist are on the same page regarding instrument sensitivity/reporting limits.
  • CRO or laboratory testing partner: Do you provide support after a submission is complete? Follow-up support on testing is important in the event that regulators pose questions or request supplemental information.
  • Standards bodies: How can OEMs and testing laboratories remain active in the conversation around new regulations? Being proactive on upcoming changes will allow you to manage potential risks associated with your device and influence the conversation to consider your perspective and capabilities. These influences can benefit the entire community by ensuring relevant terminology is put in place and timing of regulations is feasible.
  • Notified bodies: What collaborative efforts are most important from an OEM and testing laboratory? Cultivating positive relationships with notified bodies can create trust and build communication proficiencies that benefit overall compliance.

You mention performing a gap analysis. Can you explain what that would entail, who performs it, and what action plan could be put in place?

Schaible: A gap analysis is an evaluation that OEMs can use to identify missing information in pre-existing data and product portfolios. This step can take up to a few months to complete, but making this time investment at the forefront can mitigate the risk of running into additional regulatory hurdles down the road. It’s best practice to complete a gap analysis before developing a pre-clinical testing strategy. The process should involve a team of cross-functional experts from quality, project management, and engineering departments. If outsourcing your gap analysis, look to a consultant or an expert toxicologist that can demonstrate the expertise and capabilities necessary to accurately identify missing information, prioritize products, and build a robust test plan.

Questions to consider:

  • What is the age of your device? Older devices that have not undergone testing since they were originally manufactured may require more legwork. Their technical files may contain information that is insufficient under the new standards and therefore should be prioritized accordingly. There have been several updates to standards in the past few years and expectations of regulatory bodies have changed as well. For example, testing conducted only three years ago may no longer be sufficient under today’s expectations.
  • Have any changes been made to the device since it was last tested? In order to be considered ‘up-to-date’ data, all changes, even those that are minor, must be appropriately documented. Device changes could impact chemical make-up or potential risk outcomes, and regulators will be looking for data that supports the safety of all individual material components, chemical constituents and mechanical processes used on and within the device.
  • Have any patient safety issues been reported in association with the device? If you answered “yes,” you will undoubtedly need to pursue testing. This will be your opportunity to show regulators that corrective actions have been taken to rectify gaps.

Action plans to perform a gap analysis will vary by product and company, however, educating internal teams on regulatory changes, organizing technical files early on, properly vetting partners, and approaching partnerships with transparency will get you started down the right path. Get going on your gap analysis now to save time and money in your submission process.

What are some gap analysis missteps to be aware of?

Schaible: First, you should know that providing a testing partner outdated or incomplete information can negatively impact their research process. It is important to provide them with the original information in one comprehensive technical file to give them the whole picture and allow them to make informed decisions on what tests need to performed to fully support the device’s safety. The more transparent you are, the better. Second, citing old research that no longer meets quality standards of new regulation will result in a failed submission. The gap analysis is the stage at which holes in existing information are identified, so skipping this step is detrimental to your entire data package. Maintaining a proactive relationship with regulatory bodies is important in avoiding misunderstanding of current regulations or citation of outdated regulations. Finally, neglecting to present a detailed history of any changes made to the device since it was last reviewed by regulators will severely impact submission accuracy. Seemingly minor details like this could be easily overlooked without a gap analysis; however, the consequences may be catastrophic.

How can a company get started?

Schaible: Rounding up a group of the right people and resources is the first step in preparing for MDR. With a cross-functional team that is informed on the changes and business impacts of new regulation, and a planful approach your organization can ensure that devices achieve regulatory approval before deadlines go into effect. As you begin the planning process, your internal team should start collecting existing data on the materials that make up your devices, as well as procedures used in manufacturing and sterilization. This information will aid you in the planning process to ensure safety is upheld and technical files demonstrate compliance with new standards.

What are the pitfalls and how can they be avoided?

Schaible: Many of the pitfalls in preparing for MDR stem from the same seed – unpreparedness. Procrastination and disorganization will undoubtedly lead to rushed and incomplete processes and teams. OEMs must define a planning process and establish partnerships early on to avoid running into costly, time-consuming regulatory hurdles. Communicate early and often to mitigate the risk of overlooking gaps in data, educate key players on the changing regulatory landscape, and establish partnerships to develop a bulletproof pre-clinical testing strategy. On average, repeat testing can cost more than $75,000 and 27 weeks of time, so it is important to do things right the first time around and to remain systematic from start to finish.

What you Need to Know About Reusable Devices and Europe’s MDR

What you Need to Know About Reusable Devices and Europe’s MDR

Feb 18, 2020 | MDR, Medical Device, Medical Device Testing, Regulatory, Technical Expertise

Manufacturers of Class I reusable (Class Ir) medical devices need to identify data gaps and select the appropriate validation study to ensure their devices’ compliance with the European Commission’s Medical Device Regulation (MDR).

The introduction of MDR is putting increased emphasis on the roles that robust data and complete evaluations play in ensuring medical device safety. All devices, including Class I reusable devices (Class Ir), must meet the new guidelines or risk being excluded from the market.

The changes

Class Ir devices are designed to be used more than once and across patients. To obtain a CE Mark under MDR, these devices will require a detailed technical file that proves safety and efficacy of cleaning, disinfection and sterilization methods outlined in the device’s Instructions for Use (IFU). Historically, Class I devices, including reusable products, were self-designated, leaving it up to device manufacturers to decide what a validation entailed. But under MDR, every device manufacturer will be responsible for ensuring cleaning, disinfection and sterilization instructions are adequate and validated. A notified body will review the technical files, including these validations, to confirm they comply with MDR and are acceptable according to international standards and industry guidance.

As the May 26, 2020 deadline draws near, it is important to note that reusable devices won’t have the luxury of receiving an extension or being grandfathered in. Therefore, prioritize them early, starting by conducting a gap analysis and appropriate validation studies.

Conduct a gap analysis

Before investing time and money on testing, perform a gap analysis to determine where deficiencies exist in your data and product portfolios. Notified bodies will not rely on historic product performance or reviews alone.

Start by reviewing the technical files for your current Class Ir devices to identify missing information or outdated test strategies. This is especially important for MDR compliance, as you will need to confirm that validations exist in the design file that support instructions for use (IFU) claims and meet current ISO standards, including ISO 17664:2017.

Begin with legacy devices, as those have been on the market longer and will likely take more time. If a product family consists of multiple catalog numbers and SKUs, you must document validation evidence across all of the devices.

Prepare for testing

If the analysis identifies data gaps, run a validation test to rectify them and gather new data or supplemental information. This process can be laborious, but working with a contract research organization (CRO) or laboratory testing partner may help. They can identify and perform appropriate tests to ensure compliance. It is also helpful to identify a partner that can develop experimental design and validation methods that are compliant with the latest guidance and regulatory documents.

Conduct testing

If validation testing is required, start by identifying the type of study or studies needed for your product or product family. Then, validation protocols are developed and customized to your product, its IFU and worst-case conditions. Here are some examples of the studies that may be needed:

  • A cleaning efficacy study validates the efficacy of your recommended cleaning process. It requires that you test devices with clinically relevant artificial soils and other worst-case parameters that confirm the process is reliable and repeatable and ensures that clean endpoints are met.
  • Sterilization efficacy studies are used to verify that the sterilization methods successfully achieve a targeted sterility assurance level (SAL), even in worst-case scenarios.
  • Dry time validations studies are needed because healthcare facilities must know the effective dry time for devices sterilized using steam. It will be important to have data to back that the drying cycle works according to the given parameters.
  • Support functionality studies by exposing devices to multiple cleaning, disinfection and/or sterilization cycles beforehand.
  • Disinfection efficacy studies will produce documentation showing that selected disinfectants can reduce microorganisms to acceptable levels on the medical device. It is important to note that a cleaning validation and its construct is separate from a disinfection validation. Independent protocols and reports for each must be generated to document the effectiveness of each reprocessing step.

Because these studies can be costly and time-consuming, it is important to perform them properly the first time. Make sure to do the following when conducting your studies:

  • Select clinically relevant test soil
  • Simulate worst-case conditions
  • Include proper test controls
  • Use two or more cleaning endpoint markers
  • Include accumulation cycles
  • Perform recovery efficiency
  • Perform validations independently
  • Demonstrate and document appropriate test soil drying times

After testing is complete, you will need to submit your data to a notified body. However, under MDR, every notified body will have to go through a new designation and notification process before it will be eligible to review your device’s technical file and approve a CE Mark. Communicate with your notified body early and get your device in line, as the industry anticipates capacity constraints.